Myocardial InfarctionNCT05335629
Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
A study testing Dapagliflozin 10Mg Tab in people with Myocardial Infarction and Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
Trial summary
A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Diabetes Mellitus, Type 2, Myocardial Remodeling, Ventricular
- What is being tested?
- Dapagliflozin 10Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male aged >18 and < 75 years
- Diabetic post myocardial infarction patients
- First anterior STEMI with successful TIMI-3 flow
- STEMI within 12 hrs of onset of chest pain
- creatine clearance ≥60 mL/min
- HbA1c between 6.5% and 12.0%
Who cannot join
- Cardiogenic shock on admission
- Multivessel disease on admission
- Mechanical complications e.g. mitral regurge on admission
- Life threatening arrhythmia on admission
- Hemodynamic instability on admission
- Diagnosis of Type 1 diabetes mellitus
Show all 12Show fewer
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- CrCl < 60 ml/min (based on the Cockroft-Gault equation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients
A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic patients
Read the detailed description
All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Female or male aged >18 and < 75 years
- Diabetic post myocardial infarction patients
- First anterior STEMI with successful TIMI-3 flow
- STEMI within 12 hrs of onset of chest pain
- creatine clearance ≥60 mL/min
- HbA1c between 6.5% and 12.0%
Exclusion criteria:
- Cardiogenic shock on admission
- Multivessel disease on admission
- Mechanical complications e.g. mitral regurge on admission
- Life threatening arrhythmia on admission
- Hemodynamic instability on admission
- Diagnosis of Type 1 diabetes mellitus
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- CrCl < 60 ml/min (based on the Cockroft-Gault equation)
Eligible patients will be randomly assigned into one of 2 arms:
- Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
- Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
- Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
- Dapagliflozin will be administered immediately at time of PCI and daily for 4 weeks.
- Standard of care will given to both arms (group 2 and 3) and includes:
Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or aldosterone antagonist depending on the ejection fraction
- All subjects will sign an informed consent statement prior to inclusion in the study.
- All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker
- Being tested
- Dapagliflozin 10Mg Tab
- Keywords
- Dapagliflozin, ST2, Myocardial infarction, Cardiac remodeling, T2DM
- Medical subject headings
- Myocardial Infarction, Diabetes Mellitus, Type 2, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | 30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
Interventions:
Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy Receives: Drug: Dapagliflozin 10Mg Tab |
| Control arm | No intervention | 30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
patients will be followed up for the whole period of the study and blood sample will be drawn at baseline and at study end to track changes in the level of ST2 (suppression of tumerogenicity 2) which is a cardiac remodeling biomarker using ELISA technique
Measured: 4 weeks
Secondary outcomes (1)
Echocardiographic changes due to intervention
patients will have their echocardiography and ejection fraction will be compared at baseline and at the end of the study to track any changes that may be caused by intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jun 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Heshmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335629
- Sponsor's protocol ID
- Dapagliflozin and ST2
- Status last verified
- Jan 2024
- First submitted
- 28 Mar 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker ML, Perazella MA. SGLT2 inhibitor therapy in patients with type-2 diabetes mellitus: is acute kidney injury a concern? J Nephrol. 2020 Oct;33(5):985-994. doi: 10.1007/s40620-020-00712-5. Epub 2020 Feb 18.
PubMed 32067179Berezin AE, Berezin AA. Adverse Cardiac Remodelling after Acute Myocardial Infarction: Old and New Biomarkers. Dis Markers. 2020 Jun 12;2020:1215802. doi: 10.1155/2020/1215802. eCollection 2020.
PubMed 32626540Bolognese L, Falsini G, Schwenke C, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial). Am J Cardiol. 2012 Jan 1;109(1):67-74. doi: 10.1016/j.amjcard.2011.08.006. Epub 2011 Sep 22.
PubMed 21943940Broch K, Andreassen AK, Ueland T, Michelsen AE, Stueflotten W, Aukrust P, Aakhus S, Gullestad L. Soluble ST2 reflects hemodynamic stress in non-ischemic heart failure. Int J Cardiol. 2015 Jan 20;179:378-84. doi: 10.1016/j.ijcard.2014.11.003. Epub 2014 Nov 5.
PubMed 25464491Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.
PubMed 32578850Gruzdeva O, Dyleva Y, Uchasova E, Akbasheva O, Karetnikova V, Kashtalap V, Shilov A, Polikutina O, Slepynina Y, Barbarash O. Biological markers and cardiac remodelling following the myocardial infarction. Aging (Albany NY). 2019 Jun 10;11(11):3523-3535. doi: 10.18632/aging.101994.
PubMed 31182683Iwahana H, Yanagisawa K, Ito-Kosaka A, Kuroiwa K, Tago K, Komatsu N, Katashima R, Itakura M, Tominaga S. Different promoter usage and multiple transcription initiation sites of the interleukin-1 receptor-related human ST2 gene in UT-7 and TM12 cells. Eur J Biochem. 1999 Sep;264(2):397-406. doi: 10.1046/j.1432-1327.1999.00615.x.
PubMed 10491084Januzzi JL Jr, Peacock WF, Maisel AS, Chae CU, Jesse RL, Baggish AL, O'Donoghue M, Sakhuja R, Chen AA, van Kimmenade RR, Lewandrowski KB, Lloyd-Jones DM, Wu AH. Measurement of the interleukin family member ST2 in patients with acute dyspnea: results from the PRIDE (Pro-Brain Natriuretic Peptide Investigation of Dyspnea in the Emergency Department) study. J Am Coll Cardiol. 2007 Aug 14;50(7):607-13. doi: 10.1016/j.jacc.2007.05.014. Epub 2007 Jul 30.
PubMed 17692745Kokkoz C, Bilge A, Irik M, Dayangac HI, Hayran M, Akarca FK, Erdem NB, Cavus M. Prognostic value of plasma ST2 in patients with non-ST segment elevation acute coronary syndrome. Turk J Emerg Med. 2018 Feb 9;18(2):62-66. doi: 10.1016/j.tjem.2018.01.003. eCollection 2018 Jun.
PubMed 29922732Lam CSP, Chandramouli C, Ahooja V, Verma S. SGLT-2 Inhibitors in Heart Failure: Current Management, Unmet Needs, and Therapeutic Prospects. J Am Heart Assoc. 2019 Oct 15;8(20):e013389. doi: 10.1161/JAHA.119.013389. Epub 2019 Oct 12. No abstract available.
PubMed 31607208Li C, Zhang J, Xue M, Li X, Han F, Liu X, Xu L, Lu Y, Cheng Y, Li T, Yu X, Sun B, Chen L. SGLT2 inhibition with empagliflozin attenuates myocardial oxidative stress and fibrosis in diabetic mice heart. Cardiovasc Diabetol. 2019 Feb 2;18(1):15. doi: 10.1186/s12933-019-0816-2.
PubMed 30710997Ma ZG, Yuan YP, Wu HM, Zhang X, Tang QZ. Cardiac fibrosis: new insights into the pathogenesis. Int J Biol Sci. 2018 Sep 7;14(12):1645-1657. doi: 10.7150/ijbs.28103. eCollection 2018.
PubMed 30416379Mancini GB, Dahlof B, Diez J. Surrogate markers for cardiovascular disease: structural markers. Circulation. 2004 Jun 29;109(25 Suppl 1):IV22-30. doi: 10.1161/01.CIR.0000133443.77237.2f. No abstract available.
PubMed 15226248McCarthy CP, Januzzi JL Jr. Soluble ST2 in Heart Failure. Heart Fail Clin. 2018 Jan;14(1):41-48. doi: 10.1016/j.hfc.2017.08.005.
PubMed 29153199Millar NL, O'Donnell C, McInnes IB, Brint E. Wounds that heal and wounds that don't - The role of the IL-33/ST2 pathway in tissue repair and tumorigenesis. Semin Cell Dev Biol. 2017 Jan;61:41-50. doi: 10.1016/j.semcdb.2016.08.007. Epub 2016 Aug 10.
PubMed 27521518
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05335629
- Acronym / sponsor ID
- Dapagliflozin and ST2
- Keywords
- Dapagliflozin, ST2, Myocardial infarction, Cardiac remodeling, T2DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic patients
Detailed description
All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Female or male aged >18 and < 75 years
- Diabetic post myocardial infarction patients
- First anterior STEMI with successful TIMI-3 flow
- STEMI within 12 hrs of onset of chest pain
- creatine clearance ≥60 mL/min
- HbA1c between 6.5% and 12.0%
Exclusion criteria:
- Cardiogenic shock on admission
- Multivessel disease on admission
- Mechanical complications e.g. mitral regurge on admission
- Life threatening arrhythmia on admission
- Hemodynamic instability on admission
- Diagnosis of Type 1 diabetes mellitus
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- CrCl < 60 ml/min (based on the Cockroft-Gault equation)
Eligible patients will be randomly assigned into one of 2 arms:
- Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
- Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
- Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
- Dapagliflozin will be administered immediately at time of PCI and daily for 4 weeks.
- Standard of care will given to both arms (group 2 and 3) and includes:
Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or aldosterone antagonist depending on the ejection fraction
- All subjects will sign an informed consent statement prior to inclusion in the study.
- All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Drug: Dapagliflozin 10Mg Tab30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks Interventions: Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy |
| Control arm | No intervention | –30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male aged >18 and < 75 years
- Diabetic post myocardial infarction patients
- First anterior STEMI with successful TIMI-3 flow
- STEMI within 12 hrs of onset of chest pain
- creatine clearance ≥60 mL/min
Key exclusion criteria (12 listed)
- Cardiogenic shock on admission
- Multivessel disease on admission
- Mechanical complications e.g. mitral regurge on admission
- Life threatening arrhythmia on admission
- Hemodynamic instability on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10Mg TabDapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose | Drug | Intervention arm |
Primary outcome
Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
Time frame: 4 weeks
patients will be followed up for the whole period of the study and blood sample will be drawn at baseline and at study end to track changes in the level of ST2 (suppression of tumerogenicity 2) which is a cardiac remodeling biomarker using ELISA technique
1 secondary outcome
Echocardiographic changes due to intervention
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 32067179Baker ML, Perazella MA. SGLT2 inhibitor therapy in patients with type-2 diabetes mellitus: is acute kidney injury a concern? J Nephrol. 2020 Oct;33(5):985-994. doi: 10.1007/s40620-020-00712-5. Epub 2020 Feb 18.
- Background: PubMed 32626540Berezin AE, Berezin AA. Adverse Cardiac Remodelling after Acute Myocardial Infarction: Old and New Biomarkers. Dis Markers. 2020 Jun 12;2020:1215802. doi: 10.1155/2020/1215802. eCollection 2020.
- Background: PubMed 21943940Bolognese L, Falsini G, Schwenke C, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial). Am J Cardiol. 2012 Jan 1;109(1):67-74. doi: 10.1016/j.amjcard.2011.08.006. Epub 2011 Sep 22.
- Background: PubMed 25464491Broch K, Andreassen AK, Ueland T, Michelsen AE, Stueflotten W, Aukrust P, Aakhus S, Gullestad L. Soluble ST2 reflects hemodynamic stress in non-ischemic heart failure. Int J Cardiol. 2015 Jan 20;179:378-84. doi: 10.1016/j.ijcard.2014.11.003. Epub 2014 Nov 5.
- Background: PubMed 32578850Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.
- Background: PubMed 31182683Gruzdeva O, Dyleva Y, Uchasova E, Akbasheva O, Karetnikova V, Kashtalap V, Shilov A, Polikutina O, Slepynina Y, Barbarash O. Biological markers and cardiac remodelling following the myocardial infarction. Aging (Albany NY). 2019 Jun 10;11(11):3523-3535. doi: 10.18632/aging.101994.
- Background: PubMed 10491084Iwahana H, Yanagisawa K, Ito-Kosaka A, Kuroiwa K, Tago K, Komatsu N, Katashima R, Itakura M, Tominaga S. Different promoter usage and multiple transcription initiation sites of the interleukin-1 receptor-related human ST2 gene in UT-7 and TM12 cells. Eur J Biochem. 1999 Sep;264(2):397-406. doi: 10.1046/j.1432-1327.1999.00615.x.
- Background: PubMed 17692745Januzzi JL Jr, Peacock WF, Maisel AS, Chae CU, Jesse RL, Baggish AL, O'Donoghue M, Sakhuja R, Chen AA, van Kimmenade RR, Lewandrowski KB, Lloyd-Jones DM, Wu AH. Measurement of the interleukin family member ST2 in patients with acute dyspnea: results from the PRIDE (Pro-Brain Natriuretic Peptide Investigation of Dyspnea in the Emergency Department) study. J Am Coll Cardiol. 2007 Aug 14;50(7):607-13. doi: 10.1016/j.jacc.2007.05.014. Epub 2007 Jul 30.
- Background: PubMed 29922732Kokkoz C, Bilge A, Irik M, Dayangac HI, Hayran M, Akarca FK, Erdem NB, Cavus M. Prognostic value of plasma ST2 in patients with non-ST segment elevation acute coronary syndrome. Turk J Emerg Med. 2018 Feb 9;18(2):62-66. doi: 10.1016/j.tjem.2018.01.003. eCollection 2018 Jun.
- Background: PubMed 31607208Lam CSP, Chandramouli C, Ahooja V, Verma S. SGLT-2 Inhibitors in Heart Failure: Current Management, Unmet Needs, and Therapeutic Prospects. J Am Heart Assoc. 2019 Oct 15;8(20):e013389. doi: 10.1161/JAHA.119.013389. Epub 2019 Oct 12. No abstract available.
- Background: PubMed 30710997Li C, Zhang J, Xue M, Li X, Han F, Liu X, Xu L, Lu Y, Cheng Y, Li T, Yu X, Sun B, Chen L. SGLT2 inhibition with empagliflozin attenuates myocardial oxidative stress and fibrosis in diabetic mice heart. Cardiovasc Diabetol. 2019 Feb 2;18(1):15. doi: 10.1186/s12933-019-0816-2.
- Background: PubMed 30416379Ma ZG, Yuan YP, Wu HM, Zhang X, Tang QZ. Cardiac fibrosis: new insights into the pathogenesis. Int J Biol Sci. 2018 Sep 7;14(12):1645-1657. doi: 10.7150/ijbs.28103. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10Mg Tab in people with Myocardial Infarction and Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335629, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.